03 Aug
|
Theragen Lifesciences
|
Tamil Nadu
03 Aug
Theragen Lifesciences
Tamil Nadu
Role & responsibilities:
- Perform method development, validation, and routine analytical testing for APIs and formulations.
- Operate, calibrate, and troubleshoot HPLC, UHPLC, and GC instruments independently.
- Ensure all analytical activities comply with GMP, GLP, and relevant regulatory guidelines.
- Prepare, review, and maintain analytical documents, including protocols, reports, and SOPs.
- Critically evaluate analytical results, identify deviations, and implement effective corrective actions.
- Support formulation, QA, and regulatory teams during development and dossier submission stages.
- Maintain data integrity and documentation as per regulatory expectations (USFDA, EMA, MHRA, etc.).
- Participate in internal and external audits and contribute to continuous improvement initiatives.
Preferred candidate profile:
1. Hands-on expertise in HPLC, UHPLC, and GC operation and troubleshooting.
2. Robust understanding of analytical chemistry principles and method development.
3. Sound knowledge of GMP/GLP and compliance requirements for regulated markets (US &Europe;).
4. Ability to analyze complex data, solve problems, and design experiments independently.
5. Excellent communication, documentation, and report-writing skills
📌 Senior Executive (Tamil Nadu)
🏢 Theragen Lifesciences
📍 Tamil Nadu